Identity
- Trade Name
- EA50/OG6 Combo EUDAMED
- Device Name
- EA50/OG6 Combo EUDAMED
- Model / Reference
- LTC150101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972129850344 EUDAMED
- Basic UDI-DI
- 697212985OG6EA50NU EUDAMED
- Direct Marketing DI
- 06972129850344 EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMEDW01030702 CYTOCHEMICAL STAINING REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
EA50/OG6 Combo by Hunan Lituo Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697212985OG6EA50NU | Class A | Active |
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Manufacturer
- Manufacturer
- Hunan Lituo Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000029972
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 927c6243-8241-4f14-985c-4f0a9fbb71c2 61 fields · synced Oct 7, 2026
- EUDAMED 61fd8606-62d9-42c9-93a4-29941c1d23d5 61 fields · synced Jul 19, 2026